Job responsibility 工作职责
Process Development工艺开发
61 Develop downstream purification processes according to projects requirements and deliver on time;
根据项目要求，开发下游纯化工艺，并按时交付；
61 Author protocols, reports, technology transfer protocols/reports and other technical documents (i.e. Process Description, specifications) as part of the product development and technology transfer process, and responsible for writing IND-related documentation；
起草方案、报告、技术转移方案和报告，以及其他一些技术文档（例如工艺描述文件，产品说明书）作为产品开发和技术转移的一部分，并负责撰写IND相关资料的撰写。
61 Participate in project meetings as DSPD SME. Present and discuss the data and project progress at those meetings；
作为项目DSPD SME参与项目会议，并在这些会议上汇报数据和项目进展；
61 Complete protein preparation tasks according to project requirements；
根据项目需求完成蛋白制备工作；
61 Support of the technical progress and regulatory filing of related products;
支持相关产品的技术革新和监督管理。
61 Supervise technology transfer to clinical manufacturing.
监督技术转移到临床生产。
Leadership领导力
61 Assist Downstream and process development group to meet project timelines, departmental goals;
协助纯化和工艺开发小组完成项目节点和部门目标。
61 Plans and executes both routine and non-routine projects simultaneously with general criteria for results;
根据一般标准的结果，同时计划和执行常规和非常规项目。
61 Interview, mentor, and manage group members.
面试，指导和管理小组成员。

Safety and environment 现场安全和环境合规
61 Take part in the site safety through promotion of safe work place and personal action;
通过宣传安全的工作场所和个人行为，参与到工作现场的安全中。
61 Adhere to the Company’s safety and environmental protection procedures.
遵守公司的安全环保程序。

Quality Assurance 质量要求
61 Take part in Quality Management System documentation covering the development and tech transfer processes and procedures;
参与整个开发和技术转移过程和程序的质量管理体系。
61 Comply with the Company Quality Management System for development activities;
遵守公司制定的研发质量管理体系。

Qualifications 任职资格
Essential Educational and / or Training Qualifications & Certificates 需要具备的教育或培训资质&证书
61 Major in Pharmaceutics, Pharmaceutical Science or related field;
药剂学、药学或者其他相关专业。
61 Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.
相关专业的本科或硕士学历。

Necessary working Experience，type of experience，number of years 必要的工作经验、经验类型、年限要求
61 BS degree with a minimum of 4~5 years and MS degree with a minimum of 3~4 years of large Biomolecule purification experience;
本科4~5年，硕士3~4年相关生物大分子纯化经验。
61 Experience in managing staff of at least 2~4 technical specialists;
有过至少2~4人的管理经验。
61 Expert knowledge in protein biochemistry related to protein purification and characterization of MAbs and recombinant proteins;
具有单克隆抗体和重组蛋白纯化和表征的蛋白质生物化学方面的专业知识。
61 Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);
熟练使用Microsoft Office办公软件 (Word、Excel、Powerpoint、Project、Outlook)。
61 Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU.
在中国、美国和欧盟的药物制造和控制方面有丰富的实践经验。
General competency and qualified competency 所需通用素质能力及岗位胜任素质能力
61 Take responsibility of the general operation and maintenance of the protein purification laboratory facilities;
负责蛋白质纯化实验室设施的一般操作和维护。
61 Prepare and present capital expenditure requests for Downstream laboratory equipment;
准备和提出纯化实验室设备的资本支出请求。
61 Maintain effective, collaborative, and frequent interactions with client and other department to ensure harmonization in scientific and technical approaches;
与客户和其他部门保持有效、协作和频繁的沟通，以确保科学和技术方法的协调。
61 Comply with Company Policies and Procedures and contribute positively to Company Morale;
遵守公司政策和程序，积极提升公司士气。
61 Plans, executes and manages both routine and non-routine projects simultaneously with general criteria for results;
根据一般标准的结果，同时计划、执行和管理常规项目和非常规项目。
61 Other reasonably duties as requested by Company Senior Management from time to time.
完成领导提出的其他任务。

Preferred Experience 优先考虑
61 Project management of CMC filing for US, EU, and China IND/CTA;
具有美国、欧盟和中国项目申报方面的管理经验。
61 Project management training;
具有项目管理能力。
61 Formal root-cause analysis training;
严谨的问题分析能力。
61 Advanced computer system skills including: Unicorn, Empower, and DoE and statistical analysis.
高级的计算机系统能力，包括Unicorn, Empower, and DoE和统计学分析。